Contractor Quality & Regulatory Lead

Contractor Quality & Regulatory Lead

Full-Time 60000 - 80000 € / year (est.) No home office possible
Pfizer

At a Glance

  • Tasks: Lead quality projects ensuring safe products for patients while managing resources effectively.
  • Company: Join Pfizer, a patient-centric company dedicated to transforming lives through innovation.
  • Benefits: Flexible workplace culture, competitive salary, and opportunities for professional growth.
  • Other info: Diverse and inclusive environment with a commitment to employee empowerment.
  • Why this job: Make a real impact on patient lives through quality assurance in pharmaceuticals.
  • Qualifications: Experience in pharmaceutical manufacturing and strong critical thinking skills required.

The predicted salary is between 60000 - 80000 € per year.

Use Your Power for Purpose. Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve:

  • Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work.
  • Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations.
  • Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications.
  • Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management.
  • Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills.
  • Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups.
  • Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs.
  • Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues.
  • Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.

Here Is What You Need (Minimum Requirements):

  • BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience.
  • Substantial experience in pharmaceutical manufacturing and quality control.
  • Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects.
  • Knowledge of regulations related to vendor management programs and other industry quality systems.
  • Strong critical thinking skills and a proactive approach.
  • Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally.
  • Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms.

Bonus Points If You Have (Preferred Requirements):

  • Experience in Quality Systems in pharmaceutical, medical device, or combination product industry.
  • Knowledge or exposure to data science.
  • Strong leadership and team management skills.
  • Ability to work under pressure and meet tight deadlines.
  • Ability to influence and negotiate with stakeholders.
  • Experience in conducting internal audits and supporting regulatory inspections.
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
  • Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Work Location Assignment: On Premise.

Purpose: Breakthroughs that change patients' lives. At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy: One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility: We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

Equal Employment Opportunity: We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident: We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Contractor Quality & Regulatory Lead employer: Pfizer

At Pfizer, we pride ourselves on being an exceptional employer, fostering a flexible and innovative work culture that prioritises quality and patient impact. Our commitment to employee growth is evident through continuous learning opportunities and a supportive environment that values diversity and inclusion. Working on-site in our state-of-the-art facilities, you will be part of a team dedicated to transforming lives while enjoying a harmonious work-life balance.

Pfizer

Contact Detail:

Pfizer Recruiting Team

StudySmarter Expert Advice🀫

We think this is how you could land Contractor Quality & Regulatory Lead

✨Tip Number 1

Network like a pro! Reach out to current employees at Pfizer or in the pharmaceutical industry on LinkedIn. Ask them about their experiences and any tips they might have for landing a role like the Contractor Quality & Regulatory Lead.

✨Tip Number 2

Prepare for the interview by brushing up on your knowledge of cGMP and quality control processes. Be ready to discuss how you've handled compliance issues in the past and how you can contribute to Pfizer's commitment to quality.

✨Tip Number 3

Show off your leadership skills! Think of examples where you've successfully managed projects or teams, especially in ambiguous situations. This will demonstrate your ability to guide others and make decisions under pressure.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team at Pfizer.

We think you need these skills to ace Contractor Quality & Regulatory Lead

Project Management
Quality Control
Current Good Manufacturing Practices (cGMP)
Regulatory Compliance
Critical Thinking
Collaboration Skills
Communication Skills

Some tips for your application 🫑

Tailor Your Application:Make sure to customise your CV and cover letter to highlight your relevant experience in pharmaceutical manufacturing and quality control. We want to see how your skills align with the role of Contractor Quality & Regulatory Lead!

Showcase Your Problem-Solving Skills:In your application, give examples of how you've tackled complex problems in the past. We love candidates who can demonstrate critical thinking and a proactive approach, especially in ambiguous situations.

Highlight Your Teamwork Abilities:Collaboration is key in our culture! Share instances where you've effectively managed relationships and communicated well with others, as this will show us you're a great fit for our team-oriented environment.

Apply Through Our Website:We encourage you to submit your application directly through our website. This way, we can ensure your application gets the attention it deserves, and you can easily keep track of your progress!

How to prepare for a job interview at Pfizer

✨Know Your Stuff

Make sure you brush up on your knowledge of Current Good Manufacturing Practices (cGMP) and the specific regulations related to vendor management. Being able to discuss these topics confidently will show that you're serious about quality and compliance.

✨Showcase Your Problem-Solving Skills

Prepare examples of how you've tackled complex problems in the past. Think about situations where you had to make decisions independently or guide teams through ambiguous scenarios. This will demonstrate your critical thinking and leadership abilities.

✨Communicate Effectively

Practice articulating your thoughts clearly, both verbally and in writing. Since the role involves collaboration with various teams, being able to communicate your ideas and findings effectively is crucial. Consider doing mock interviews to refine your delivery.

✨Be Ready for Technical Questions

Expect questions that dive into your experience with quality systems and internal audits. Brush up on your technical knowledge and be prepared to discuss how you've used tools like Trackwise or Documentum in your previous roles. This will help you stand out as a knowledgeable candidate.